Class 2 Device Recall Bard

• Date Initiated by Firm: December 20, 2023
• Date Posted: January 25, 2024
• Recall Status: Open, Classified
• Recall Number: Z-0796-2024
• Recall Event ID: 93679
• 510(K)Number: K960176
• Product Classification: Tube, double lumen for intestinal decompression and/or intubation - Product Code FEG
• Product: Bard¿ Nasogastric Sump Tube with PreVent¿ Anti-Reflux Filter with ENFit, 10Fr., 36in Long, REF EN0046100
• Code Information: UDI/DI 00801741113222, Lot/Serial Numbers: NGDX0768, NGDZ3314, NGER3568, NGFT5023, NGFV3443, NGFW1904, NGFX0156, NGFX5525, NGGQ8459, NGGW4504
• Recalling Firm/ Manufacturer: C.R. Bard Inc; 8195 Industrial Blvd Ne; Covington GA 30014-1497
• For Additional Information Contact: 770-784-6100
• Manufacturer Reason for Recall: BD (C.R. Bard) has received user complaints reporting that during use of BD Bard NG Sump Tubes with ENFit Connectors, inadequate or reduced suction, decompression, and drainage occurred.
• FDA Determined Cause: Under Investigation by firm
• Action: BD (C.R. Bard) issued an URGENT Medical Device Recall Notice to its consignees via FedEx and email. The notice explained the problem with the devices, potential risks, and the devices be removed, quarantined, and discarded. Disseminate the notice to all users within the facility. If you have purchased this product through a distributor, please contact this distributor to request appropriate credit or order alternate replacement product. Complete and return the attached Customer Response Form to the BD contact noted on the form confirming acknowledgement of the correction notification, whether or not you have any affected product, so that BD may confirm your receipt of this notification and provide credit or alternate product. In addition to the information above, Distributors were directed to take the following actions: Please discontinue distribution of all product codes in the table above, and immediately dispose of all affected product remaining in your possession in accordance with your local facility s process. 2. Identify all customers within your distribution network that purchased any affected product as defined in this notification. Provide a copy of the attached customer letter to all customers to advise them of this field action notification on BD s behalf. Attachment 2 3. Complete the attached Distributor Response Form and return to the BD contact noted on the form confirming acknowledgement of the recall notification, whether or not you have any of the impacted product, so that BD may acknowledge your receipt of this notification. 4. Indicate on the response form the quantity of product identified at your facility and confirm that this inventory was destroyed. Attachment 1 5. Please contact your BD representative if you require assistance with credits to be issued for discarded products or for replacement product options. You may also contact the number below for further assistance.
• Quantity in Commerce: 6600 units
• Distribution: US
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.

• 510(K) Database: 510(K)s with Product Code = FEG and Original Applicant = C.R. BARD, INC.